NCT04854187

Brief Summary

This is a randomized controlled trial to evaluate personal protective aids (air purifier and N95) as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5 in India.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

March 30, 2021

Last Update Submit

October 21, 2024

Conditions

Pollution; ExposureHTNDiabetes Mellitus

Keywords

Air pollutionHTNDMN95 maskIndoor air purifier

Outcome Measures

Primary Outcomes (2)

  • Absolute change in systolic blood pressure for people with hypertension using air purifier and facemask

    We will monitor blood pressure at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.

    4 weeks

  • Absolute change in fasting blood glucose for people with diabetes using air purifier and facemask

    We will monitor fasting blood glucose at week 0,2,4 of both intervention and control period. Outcome would be measured as difference in the mean systolic blood pressure between both arms.

    4 weeks

Study Arms (3)

Intervention Arm - Indoor air purifier and N95 mask

ACTIVE COMPARATOR

Intervention arm will be for 4 weeks. Blood pressure and/or blood glucose will be recorded on day 0; end of week 2 and end of the intervention. Participants in the intervention group will be asked to use an indoor air purifier (Atlanta Healthcare 7-Stage 43-Watt Air Purifier) daily for 4 weeks between the hours of ¬8 PM and 8 AM. The purifier will be placed in their bedroom or in the room where participants sleep at night. When the participants are outdoors (commuting, working outdoors, running errands, etc.), they will be asked to use a N95 mask (PureMe Reusable N95 Anti-Pollution Mask). It is a reusable mask which can be washed by the participants. Every 2 weeks, the filter of the mask will be replaced, and the filter of the indoor purifier will be washed.

Device: N95 Mask/Indoor air purifier: Including sham

Washout period - No intervention

NO INTERVENTION

At the end of either control or intervention arm, participants will have a washout period of 2 weeks, after which participants will be crossed over to the other group for the subsequent 4 weeks. For example, after Participant AB is in intervention arm for 4 weeks, he/she will then have a wash out period of 2 weeks in which they will return to their usual state of living. At the end of the washout period, the participant AB will be put in the control arm for 4 weeks.

Controlled Arm - Indoor air purifier and N95 mask with sham filter

SHAM COMPARATOR

Control arm will be for 4 weeks. Blood pressure, blood glucose and indoor air pollution level will be recorded similarly as in the intervention group on day 0, end of week 2 and week 4. The participant will be provided an air purifier and a N-95 mask (of the same manufacturer), with the filter removed. At the end of two weeks, the health worker will make dummy adjustments to the mask and indoor air purifier, to maintain blinding of the participant.

Device: N95 Mask/Indoor air purifier: Including sham

Interventions

N95 Mask/Indoor air purifier: Including shamDEVICE

Participants will be using indoor air purifier and N95 mask (control arm with sham filters). The effect will be studied on blood pressure and blood glucose levels.

Controlled Arm - Indoor air purifier and N95 mask with sham filterIntervention Arm - Indoor air purifier and N95 mask

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension arm
  • Individuals age 18-70 years old with systolic blood pressure between 130-160 mmHg, regardless of medication use
  • Stable hypertension for the past 3 months with no medication changes
  • No planned medication changes for the duration of the study
  • Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
  • Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
  • Use of gas (LPG)/electricity for cooking purposes
  • Diabetes arm
  • Individuals age 18-70 years old with fasting blood glucose between 126-180 mg/dL, regardless of medication use
  • Stable diabetes for the past 3 months with no medication changes
  • No planned medication changes for the duration of the study
  • Exposure to outdoor air pollution above a certain threshold (pollution levels will be measured using AirVeda devices)
  • Individuals who sleep in a closed space (such as a bedroom) for minimum of 6 hours/daily.
  • Use of gas (LPG)/electricity for cooking purposes

You may not qualify if:

  • Unwilling to participate
  • Unstable blood pressure and/or blood glucose level requiring frequent medication changes
  • Individual suffering from a physical or mental illness that precludes active study participation
  • Current smoker
  • Planned vacation/absence from the study site
  • Patients with life expectancy \< 12 months
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Charitable trust

Dalkhola, West Bengal, 733201, India

Location

Related Publications (1)

  • Barbhaya D, Tran J, Khetan A, Hejjaji V, Jain S, Chan C, Goel A. Rationale and Design of a Study to Test the Effect of Personal Protective Aids on Hypertension and Diabetes in People Living With High Levels of Air Pollution-Study Protocol. Heart Lung Circ. 2023 Jan;32(1):124-130. doi: 10.1016/j.hlc.2022.11.001. Epub 2022 Dec 15.

    PMID: 36528547DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dweep Barbhaya, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Aditya Khetan, MD

    Hamilton Health Sciences, McMaster University, Hamilton, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Prospective, randomized cross over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 22, 2021

Study Start

March 25, 2021

Primary Completion

October 17, 2024

Study Completion

October 17, 2024

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)